K202433 is an FDA 510(k) clearance for the Aqueduct 200 Cervical Dilation Balloon Catheter. This device is classified as a Catheter, Balloon, Dilation Of Cervical Canal (Class II - Special Controls, product code PON).
Submitted by Gtimd, LLC (Amherst, US). The FDA issued a Cleared decision on October 15, 2021, 416 days after receiving the submission on August 25, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4260. Mechanical Dilation And Softening Of The Cervix..
| 510(k) Number | K202433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2020 |
| Decision Date | October 15, 2021 |
| Days to Decision | 416 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PON - Catheter, Balloon, Dilation Of Cervical Canal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4260 |
| Definition | Mechanical Dilation And Softening Of The Cervix. |